Electrocardiographic Data Quality in Thorough QT/QTc Studies
Most drugs with systemic bioavailability have to undergo a thorough QT (TQT) study, which includes…
Certara2014 年 3 月 1 日
In Vitro-In Vivo Extrapolation of Drug-induced Proarrhythmia Predictions at the Population Level
Drug cardiotoxicity is a serious issue for patients, regulators, pharmaceutical companies and health service payers…
Certara2014 年 3 月 1 日
Precision Criteria to Derive Sample Size When Designing Pediatric Pharmacokinetics Studies: Which Measure of Variability Should be Used?
A new approach for calculation of sample size in pediatric clinical pharmacokinetic studies was suggested based on desired precision for a pharmacokinetic parameter…
Certara2014 年 3 月 1 日
Population Pharmacokinetic Analysis of Axitinib in Healthy Volunteers
Axitinib is a potent and selective second generation inhibitor of vascular endothelial growth factor receptors…
Certara2014 年 2 月 21 日
A Model-based Meta-analysis to Compare Efficacy and Tolerability of Tramadol and Tapentadol for the Treatment of Chronic Non-malignant Pain
Pain is a major symptom in many medical conditions which can be relieved thanks to…
Certara2014 年 2 月 13 日
Hyperlinking: Making the Most of Navigation in eCTD Submissions
When authors generate documents intended for electronic submission they use blue-colored font to indicate where…
Certara2014 年 2 月 5 日
A Systems Pharmacology Perspective on the Clinical Development of Fatty Acid Amide Hydrolase Inhibitors for Pain
The level of the endocannabinoid anandamide is controlled by fatty acid amide hydrolase (FAAH). In…
Certara2014 年 1 月 15 日
Simplifying Deconvolution
Deconvolution is used to evaluate the absorption kinetics of a drug. Unfortunately the term can…
Certara2014 年 1 月 13 日
The IQ-CSRC Prospective Clinical Phase 1 Study: Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?
A collaboration between the Consortium for Innovation and Quality in Pharmaceutical Development and the Cardiac…
Certara2014 年 1 月 1 日
